Impact of Beta-blockers Among Patients Undergoing TAVI: a Randomized Multicenter Trial
This is a prospective, multicentre, investigator-initiated, randomized clinical trial clinical trial investigating the impact of beta-blockers administration among patients undergoing TAVI for severe aortic valve stenosis. Adults already receiving beta-blockers be assigned randomly in 1:1 ratio to either continue or withdraw the beta-blockers medication at least 72 hours before and at least 7 days after TAVI. The primary endpoint is permanent pacemaker implantation rates in 7 days after the procedure. Secondary endpoints include death, cardiogenic shock and arrhythmias/conduction abmormalities with time frame 12 months.
• Adults ≥18 years old.
• Patient with severe symptomatic aortic stenosis defined by mean aortic gradient \> 40 mmHg or/and peak jet velocity \> 4.0 m/s or/and aortic valve area (AVA) \< 1cm2 or/and AVA indexed to body surface area (BSA) of \<0.6 cm2/m2.
• Patients are considered at high risk for mortality with conventional surgical aortic valve replacement as assessed by a Heart Team consisting of at least a cardiologist and surgeon.
• Patients with anatomic characteristics suitable for TAVI based on the local Heart Team decision.
• Patients receiving beta-blockers as a part of their indicated treatment plan.
• Patient understands the purpose, the potential risks as well as benefits of the trial and is willing to participate in all parts of the follow-up.
• Patient has given written consent to participate in the trial.